Accuracy Testing of Validated and Non-validated Home BP Devices Sold on the Online Market. (VALID-HomeBP)

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Status: Enrolling

Conditions: Hypertension

Treatments: Diagnostic Test: awake ABPM

Study type: Interventional

Funder types: Other

Identifiers

NCT06688409

VALID-HomeBP

Details and patient eligibility

About

This study aims to assess whether validated and non-validated blood pressure measuring devices sold on the online market are accurate in regards to the mean awake BP from ambulatory blood pressure monitoring.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged > 18 years scheduled to undergo an ABPM

Exclusion criteria

• Upper arm size outside of cuff range of selected devices (<22 cm or >42 cm)
• Night shift workers
• Permanent atrial fibrillation
• Known severe aortic stenosis
• Contraindication to measure BP on the non-dominant arm
• Ongoing pregnancy
• Inability or unwillingness to provide consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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140 participants in 4 patient groups

Validate home BP device

Active Comparator group

Description:

BP measured with a validated home BP device

Treatment:

Diagnostic Test: awake ABPM

Non-validated home BP device #1

Active Comparator group

Description:

BP measured with the first non-validated home BP device

Treatment:

Diagnostic Test: awake ABPM

Non-validated home BP device #2

Active Comparator group

Description:

BP measured with the second non-validated home BP device

Treatment:

Diagnostic Test: awake ABPM

Non-validated home BP device #3

Active Comparator group

Description:

BP measured with the third non-validated home BP device

Treatment:

Diagnostic Test: awake ABPM